Operations
Clean-Path vs Amended — approved studies side-by-side
Clean-path approved
664
no rejection, no amendment
Amended approved
5,418
≥ 1 amendment on file
Clean — avg approval
28.0 d
median 22 d
Amended — avg approval
66.6 d
median 42 d
Avg amendments per study
1.4
amended cohort only
Speed gap
+38.6 d
amended slower than clean
Cohort split
Share of approved studies in each cohort
Side-by-side summary
Average and median days for each phase
| Metric | Clean (n=664) | Amended (n=5,418) | Delta (amended − clean) |
|---|---|---|---|
| Submission → approval — avg | 28.0 d | 66.6 d | +38.6 d |
| Submission → approval — median | 22 d | 42 d | +20 d |
Average days to approval — clean vs amended
Lower is better
Days to approval — clean
Days to approval — amended
Average days to approval by submission year — clean vs amended
Watch how the gap between the two cohorts evolves year by year
Amendments per amended study
How many revisions amended studies typically go through (avg 1.4)